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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Sensitisation data (human)

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Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
publication
Title:
The activity and safety of the antimicrobial agent Bronopol (2-bromo-2-nitropropan-1,3-diol).
Author:
Bryce D M, Croshaw B, Hall J E, Holland V R, Lessel B
Year:
1978
Bibliographic source:
J Soc Cosmet Chem 29: 3 - 24

Materials and methods

Type of sensitisation studied:
skin
Study type:
other: study with patients

Test material

Constituent 1
Chemical structure
Reference substance name:
Bronopol
EC Number:
200-143-0
EC Name:
Bronopol
Cas Number:
52-51-7
Molecular formula:
C3H6BrNO4
IUPAC Name:
2-bromo-2-nitropropane-1,3-diol

Method

Type of population:
other: patients attending a contact dermatitis clinic
Ethical approval:
not specified
Subjects:
149 patients attending a contact dermatitis clinic
Route of administration:
dermal
Details on study design:
Concentrations: 0, 0.5, 1 and 2 % bronopol in pet., and 0, 0.05, 0.1 and 0.25 % in aqueous buffer at pH 5.5.

Results and discussion

Results of examinations:
1 % in pet. slight erythema in 2/10,
2 % in pet. moderate erythema in 4/10,
0.25% in aq. 1/10 slight erythema.
No evidence of sensitization was seen.

Applicant's summary and conclusion